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A Phase I Study: PET Imaging of Cancer Patients Using [18F] 4-L-Fluoroglutamine (2S,4R)
Sponsor: Memorial Sloan Kettering Cancer Center
Summary
This is a Phase I study. This study is the first time that a new experimental drug called 18FFluoroglutamine, or F-Glutamine, is being used in people. F-Glutamine is a drug designed to be used with PET scanners that can 'see' where F-Glutamine goes in the body, after its injected. PET scanners are one of the kinds of scanners you normally find in a hospital radiology department. The researchers have found that tumors in animals absorb F-Glutamine. The researchers believe that scans with F-Glutamine might be able to find tumors in patients. This first in-human study is being done to see how long F-Glutamine lasts in the blood, when it is given to people in tiny amounts by an injection, and to see where F-Glutamine goes in the body. If the results of this trial are good, then the study doctors plan to use F-Glutamine in another trial to see if scans with F-Glutamine are better for finding tumors compared to the standard types of scans that doctors use.
Key Details
Gender
All
Age Range
21 Years - 90 Years
Study Type
INTERVENTIONAL
Enrollment
67
Start Date
2012-09
Completion Date
2026-09
Last Updated
2025-10-15
Healthy Volunteers
No
Conditions
Interventions
[18F] 4-L-Fluoroglutamine (2S,4R)
Thirty cancer patients will receive an injection of a 0.5 to 7.5mCi of \[18F\] 4-LFluoroglutamine (2S,4R) , followed by serial PET/CT scanning and blood draws, (at the direction of the investigator) over a period of 3.5 hours, on a single day. Each patient will be offered the opportunity to repeat the \[18F\] 4-L-Fluoroglutamine (2S,4R) injection and subsequent set of post-injection PET-CT scans, once, on a separate date. At the discretion of the investigator, scan 3 can be waived. Immediately prior to injection of the radiotracer, a blood sample will be obtained for measurement of serum glutamine level. The serum glutamine level will be assayed, if necessary, as part of an amino acid screen assay.
Locations (1)
Memorial Sloan Kettering Cancer Center
New York, New York, United States